INDUSTRY NEWS

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Corium Receives FDA Approval of ADLARITY® (donepezil transdermal system) for Treatment of Patients with Alzheimer’s Disease

April 7, 2022

Original Source Boston, MA, March 14, 2022 – Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) has approved Corium’s ADLARITY (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia of the…

PE-backed Angstrom Technology pursues acquisitions to fill cleanroom market gaps

April 7, 2022

Original Source WALKER — A couple of recent strategic acquisitions should further prepare cleanroom designer and builder Angstrom Technology Ltd. for overseas projects as the company continues a private equity-backed string of acquisitions. After New York City private equity firm ASGARD Partners & Co. acquired a controlling interest in Angstrom in November 2020, Angstrom has persued deals to expand…

Senior Biopharma Executive Joins MMS Holdings as Principal Medical Director

April 7, 2022

CANTON, Mich. (3/10/2022) – MMS Holdings, a data-focused contract research organization (CRO), announced the addition of Robert Allen, MD, to its team as Principal Medical Director of Global Drug Safety and Pharmacovigilance. Bringing more than 20 years of pharmaceutical industry experience, Dr. Allen has worked at Parke Davis, Pfizer, Adolor, AstraZeneca, Wyeth, Scirex, Premier, and…

Adoption of Research Animals – State Policy

March 4, 2022

MichBio testified before the House Regulatory Reform Committee on HB 4881 and HB 4882, sponsored by Reps. Kevin Hertel (D-St. Clair Shore) and Tommy Brann (R-Wyoming) respectively, would require research facilities to offer dogs or cats used in laboratory research up for adoption prior to euthanizing them. Additionally, facilities would be required to submit annual…

Proposed Formation of Prescription Drug Affordability Board – State Policy

March 4, 2022

Sen. Brinks (D-Grand Rapids) and Rep. Camilleri (D-Trenton) introduced SB 889 and HB 5842, respectively that would establish a Prescription Drug Affordability Board (PDAB), similar to those already established in Colorado and Maryland. These bills, along with other companion bills, make up a package that would determine rates, set limits and cap how much up-charging can be done on…

MichBio Supports Emphasis on Education and Talent Development – State Policy

March 4, 2022

MichBio co-signed a letter from the University Research Corridor (URC) and Michigan Association of State Universities (MASU) as part of a testimony package presented to the Senate Appropriations Subcommittee on Universities and Community Colleges by MASU Director, Dan Hurley. Michigan has an opportunity to do a great many things to set the course for long…

Rare Disease Advisory Council – State Policy

March 4, 2022

Legislation that proposes to establish a Rare Diseases Advisory Council, HB 4654, had a hearing by the Senate Health Policy Committee. MichBio reiterated its desire for some changes, particularly the inclusion of a representative from the Association or a Michigan biotech/pharma company working in rare diseases. A bill substitute containing such language and a few…

BIO Releases Report on Policy Best Practices

March 4, 2022

BIO, in partnership with the CSBA, released a new report on bioscience economic development and legislative policy best practices, “Driving the Bioscience Economy Forward During the COVID-19 Pandemic: Best Practices in State and Regional Economic Development Initiatives.” The report, which reviewed public policy strategies and programs in all 50 states, highlights new and innovative initiatives…

MichBio Joins to Decry CMS Coverage Decision

March 4, 2022

MichBio was part of a letter under the auspices of the Council of State Bioscience Associations (CSBA) to the Centers for Medicare and Medicaid Services (CMS) regarding the agency’s unprecedented National Coverage Determination (NCD) decision to limit seniors’ access to an entire class of Alzheimer’s drugs. A great op-ed by Dr. Michelle McMurry-Heath, President and…

MichBio Signs on to Letter Opposing March-In Rights Petition

March 4, 2022

A petition was refiled with the federal government, in this instance with the Department of Health & Human Services, seeking to grant march-in rights for the patents on Xtandi, a prostate cancer drug, because of its alleged exorbitant price. March-in rights are rights granted to the federal government. These allow the government to grant patent…

FDA User Fee Act Reauthorizations

March 4, 2022

The reauthorization process for the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), Biologic Drugs User Fee Act (BDUFA) and Medical Device User Fee Act (MDUFA) is underway. These run on a 5-year cycle and require Congressional enactment that authorizes the Food and Drug Administration (FDA) to collect user fees from…

FDA Urges Companies to be ’Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

March 3, 2022

Original Source Today, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled…

Kalamazoo lab filled COVID testing void. As cases wane, it eyes next step.

March 3, 2022

KALAMAZOO—Visitors to the city’s downtown pedestrian mall may not notice that a door to an important link in Michigan’s $28 billion life sciences industry is tucked into a busy parking deck. This office is where Genemarkers recognized during the early weeks of the COVID-19 pandemic that its lab, which performed R&D testing for skin care products, could turn…

Analytical laboratory makes lasting “Impact” on Midland

March 3, 2022

Original Post Not all heroes wear capes — some wear lab coats. Personal care products, pharmaceuticals, and medical devices need to be tested to ensure they meet industry standards for our safety. Think: anesthetics are delivered directly into the human body, so they must be uncontaminated; heart medications need to navigate through the body and…

RTI Surgical Announces Spin Off of Businesses into Two Independent Companies

February 3, 2022

Original Source ALACHUA, Fla., Jan. 4, 2022 /PRNewswire/ — RTI Surgical, a global private label OEM company, announced today that the company will spin off its Metals business, creating two independent companies that are focused on the needs of customers and patients in their distinct market segments. Ownership of both companies will be retained by Montagu,…